NCT03093506

Effects of Micro-dose and Low-dose Recombinant Human Erythropoietin on Mitochondrial Function and Cognitive Performance

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 25 (actual)
• Sponsor: Bispebjerg Hospital · Academic / Other
• Sex: Male
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

Summary

A recent study by Plenge et al. revealed that rhEpo treatment enhances skeletal muscle mitochondrial respiratory capacity in humans indicating a muscle ergogenic effect of rhEpo on aerobic metabolism. The main purpose of the present study is to determine if a shorter treatment period with micro-dose as well as low-dose rhEpo has similar effects on muscle mitochondrial function. Higher doses of rhEpo is known to increase cognitive performance, but it is not clear if lower doses of rhEpo have similar effects. A second purpose of the present study is to determine if micro-dose as well as low-dose rhEpo increases cognitive performance.

Detailed description

Twenty-five healthy young male volunteers are randomized to either a low-dose rhEpo (60 IU/kg/week), micro-dose rhEpo (20 IU/kg/week), or placebo control (saline) group. All subjects receive two subcutaneous injections per week for four weeks. Muscle biopsies are taken at the beginning and end of the study period. Mitochondrial function is measured in permeabilized fibres using high-resolution respirometry with the substrates malate (2mM), octanoyl carnitine (1.5mM), glutamate (10mM), succinate (10mM), under saturating \[ADP\] (5mM), and with the membrane uncoupler FCCP (1μM). On the first day before administration of rhEpo and after the four weeks' treatment the subjects are undergoing two cognitive performance-tests, Raven Standard Progressive Matrices (Raven), and Number Finder (NUFI). Weekly semi-structured interviews are conducted by a blinded interviewer focusing on experienced change in cognitive performance.

Conditions

• Human Volunteers

Interventions

Type	Name	Description
DRUG	Low-dose rhEpo	60IU/kg/week
DRUG	Micro-dose rhEpo	20IU/kg/week
OTHER	Placebo Control	Saline

Timeline

• Start date: 2011-09-01
• Primary completion: 2011-12-01
• Completion: 2011-12-01
• First posted: 2017-03-28
• Last updated: 2017-03-28

Locations

1 site across 1 country: Denmark